CN1968670A - Inhaler using pods - Google Patents

Inhaler using pods Download PDF

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Publication number
CN1968670A
CN1968670A CNA2005800200064A CN200580020006A CN1968670A CN 1968670 A CN1968670 A CN 1968670A CN A2005800200064 A CNA2005800200064 A CN A2005800200064A CN 200580020006 A CN200580020006 A CN 200580020006A CN 1968670 A CN1968670 A CN 1968670A
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CN
China
Prior art keywords
box
medicament
inhaler device
zle
container
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
CNA2005800200064A
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Chinese (zh)
Inventor
C·弗里伯格
M·默曼
L·卡克斯
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Mederio AG
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Mederio AG
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Filing date
Publication date
Application filed by Mederio AG filed Critical Mederio AG
Publication of CN1968670A publication Critical patent/CN1968670A/en
Pending legal-status Critical Current

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J3/00—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
    • A61J3/02—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of powders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00—Inhalators
    • A61M15/0028—Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M11/00—Sprayers or atomisers specially adapted for therapeutic purposes
    • A61M11/001—Particle size control
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00—Inhalators
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2202/00—Special media to be introduced, removed or treated
    • A61M2202/06—Solids
    • A61M2202/064—Powder

Abstract

A medicament container for carrying a metered, finely divided, dry powder medication dose is disclosed. The medicament container, which is intended for administration by a dry powder inhaler device, constitutes a pod presents a bottom surface acting as a dose bed adapted for receiving a metered medication dose. The metered dose, carried by the pod, is protected from foreign matter, particularly moisture, after a sealing of the pod with a high barrier seal foil, which transforms the pod into a high barrier container. Furthermore the pod is formed such that the pod sealing foil can be slit open from a point of penetration at a first pod end to a point of exit at a second pod end by a cutter set in motion relative to the pod.

Description

Utilized the inhaler of box
Technical field
The present invention relates to use the metering dry powder doses that is encased in the container, be specifically related to single or multiple containers and be inserted in the dry powder inhaler (DPI) method and apparatus in order to delivery of medicaments.
Background
In current medical services, offer medicine with multitude of different ways.In medical and health work, medicament directly can be dropped into patient's air flue by inhaler with powder type and carry in effective, quick and user-friendly mode with pulmonary makes the powder medicine, its degree of concern increases fast.Usually be much better than for example oral capsule owing to suck the effect of medicament, thereby the dosage that is sucked only is the part of oral capsule Chinese medicine powder.So just constantly require reagent combination and packing method can be used for preparing the small but excellent true suction medicament of dry-type with low relative standard deviation (RSD).
The capacity filling is the most general method of production metered doses of medicament.Usually, the first step is with machinery such as piston many powder to be introduced in the storage of specific volume, perhaps can rely on power for support and/or suction loads storage.Many storages can be arranged on the metered doses of medicament forming device, this kind equipment is applicable to such machinery, the latter can with many containers for example blister spare or capsule aim at corresponding storage, powder can be drained in the container.Above-mentioned metered doses of medicament forms storage equipment and can integrally be located in the loader, so that how many storages is successive endless form filling and emptying.Above-mentioned technology can be known from the data of for example following announcement: EP 0 319 131B1, WO 95,/21 768, US 5,826,633, US 6,267,155 B1, US 6,581,650B2, DE 2 0,209 156 U1, WO 03,/02 6965 A1, WO 03/66436 A1 and WO03/66437 A1.
The active substance of the dry powder form that is suitable for sucking needs thin subdivision, so that the aerodynamic force diameter (AD) of the most powders in the powder is 1～5 μ m.Powder suction greater than 5 μ m can not be deposited in the lung often, and tends to adhere in the oral cavity or in the upper airway, and these powders have been wasted medicine at this, even can bring deleterious seondary effect.But the divided powder that is suitable for sucking seldom can free-flow, and regular meeting adheres on all surface that they contact, and little powder trend towards conglomeration, this be since thin De Waersili generally greater than the gravity that acts on diameter≤10 μ m powders.Therefore, metering and discharge correct number drying, can suck powder agent when medicine container for example steeps in the shape part, nominal dose quality is healed little just more difficult.Because most active agents have extremely strong drug effect, thereby only need the part milligram in a dosage as a rule.So before beginning to make metered doses of medicament will with suitable physiology inert excipients for example lactose come the diluted acid medicament.Today, nominal inhalation dose is less than 1mg even be not rare less than 0.5mg.With the prior art method is to be difficult to metering and the so little dosage of filling.For example referring to US patent No.5,865,012 with PCT bulletin WO 03/,026 695 A1.
The practice that medical industry is general is this class active substance of dilution, the nominal dosage material of this kind is increased to the level that can handle with the packing method of selecting.Generally, the quality of the capacity dosage institute tool in the prior art is 5～50mg.This usually meaning material will by 1,000 times of diluted acids or more than.But be difficult to determine whether uniform mixing of active substance and diluent materials, also be difficult to guarantee in the filling of potion dose that each of the medicament that measured is correct with active matter quality in all medicaments.If for example comprised in this kind medicament that big powder improves flowability, then must this powder of handled in order to avoid the powder layering, and this layering is in transportation be incident when handling powder.Big powder tends to be parked in the top of storage chamber and often the make a decision bottom in chamber of little powder, causes inconsistent mixing ratio between segmentation medicament that so naturally can be in the powder that is stored and big the excipient.
The method of the formation metered doses of medicament of a kind of prior art has more recently adopted static or electromotive field depositing operation or in conjunction with the two.With charged medicated powder deposit to an end part for example electrostatic chuck or the metering part on.Adopt the method for the deposition microgram of electric field technology and milligram quantities dry powder to be disclosed among the applicant's etc. U.S. Patent No. 6,592,930 B2, its whole content has been incorporated among the application as a reference.The example that is formed at the suitable dose medicated powder on the end part is referred to as the electric dosage medicine.Electric dosage medicine one speech proposes in applicant's etc. Swedish patent SE 0003082-5 (WO02/18000), and the content in this patent document has been incorporated herein by reference, and what relate to is the pre-potion medicated powder that measured of intending being used for Diskus.Above-mentioned electric dosage medicine is by comprising that active amylaceous substance or dry powder composition form with or without one or more excipient, and this electric dosage medicine is to be formed on the end part, and this end part then is the part of metered doses of medicament part.The electric dosage medicine of Xing Chenging has provided suitable character at aspects such as area occupied, powder profile, granularity, quality, the porosity, cohesives in a manner described, prevented from caking when being used for suitable dry powder inhaler device and be easy to be distributed to air.
Another problem that the user of above-mentioned prior art metered doses of medicament manufacture method faces is when this medicament can be used for Diskus (DPI) corresponding powder not to be lumpd.Because what preferentially will consider in this prior art manufacture method is that to make almost be free flowable powder medicament, between the powder batch of material, realize little fluctuation simultaneously so that in each metered doses of medicament, realize concordance, as in DPI, making the non-caking problem of medicament then not be subjected to identical attention.So the effect of this medicament drops to second-rate level, the fine silt ratio in the medicament of this kind output usually is less than 25%.With so that superfine particle shape medicament powder atomizing and being disclosed in applicant's etc. WO 03/086515 A1 and WO 03/086517A1 from the method and apparatus that DPI flows to the user who sucks medicament, their content is incorporated herein by reference.
At United States Patent (USP) 5,590,645,5,860,419,5,873,360,6,032,666,6,378, in 519 and 6,536,427, described the Diskus that is used for the medicament that measures in advance at container that adopts peelable lid paper tinsel, illustrated simultaneously for inhalant some concrete medicated powder.Above-mentioned peelable lid paper tinsel explanation is to be made by laminated piece, comprises 50g/m 2Decolouring kraft paper, 12 microns polyester (PETP) paper tinsel, 20 microns flexible toughness aluminium foil, the 9g/m of salable PVC 2The strippable heat seal glued membrane of ethylene matter (HSL), and the lamination bed material that comprises the orientation polyamide of 100 microns PVC, 45 microns flexible toughness aluminium foils and 25 microns.This HSL is sealed to after powder medicine is loaded into the intracavity that forms in the end laminated piece on the PVC layer of this end laminated piece.Above-mentioned inhaler is open before being ready for suction to go out powder medicine, then medicament be exposed to surrounding and from user any may dampness in.Strippable HSL far seals for responsive being difficult to than nonvolatil foil seal.Thereby generally provide the shelf-life that outside high barrier layer remains to inhaler, make this strippable HSL can in the operating period, protect medicated powder.
Because any medicated powder of not removing from the heat seal surface will have a strong impact on airtight quality, thereby the filling process is very important.Ideal packing method will not allow medicated powder deposit on the sealing surface in the filling process.Using mutually independently component of machine according to dosage is loaded into medicated powder in the box or intracavity or the equipment to the medicament bed surface have been described among WO 03027617 A1, WO 03066437 A1, WO 03066436 A1, WO 03026965 A1, WO 0244669 A1 and DE 100 46 127A1, DE 200 09 156 U1.
Described a kind of inhaler in WO 02/00280 A2 and US 6,655,381 B2, the magazine loader that it comprises keeps an inflexible modular magazine, and the latter has the reservoir of many integral body.Each reservoir will hold the dry powder pharmaceutical of metering in advance by the paper tinsel sealing.This paper tinsel is described as thin plastic in the 6th page of the 24th row of WO 02/00280 A2, this is uncomfortable as high resistant retaining sealing member.
The inhaler that is described among WO 03/66470 A1, GB 02 385 020 A and WO 03/15857 A1 has been used the branch compartment and has been held medicament.This compartment has first and second that will utilize the paper tinsel sealing.There is only parts design to be used for before sucking, paper tinsel being staved in each compartment, discusses in the above-mentioned patent document and the special part that weakens is set in paper tinsel makes paper tinsel be easy to open and more reliable.When medicament needs high shielding part sealing to avoid damaging, paper tinsel weakened and to constitute problem.
Among WO 01/30430 A1 dosimeter that is used for dry powder pharmaceutical has been described.This dosimeter for example can be packed in the WO 02/00279 described dried medicated powder inhaler, this dosimeter have one in sleeve slidably chamber and one can be assembled to the openable closure member in the dried medicated powder inhaler, above-mentioned dosimeter be illustrated as have one with sleeve same diameter and the lid made by friable material.So an individual components can be pushed this lid or stave open this friable material in the dosimeter.
Describe a kind of dried medicated powder inhaler among US 2002/0033176 A1, wherein can install a medicine box.This inhaler utilizes one to suck the part flow arrangement that starts, and pierces through medicine box by a lance shape spare, triggers the output of medicament.
The metered doses of medicament inhaler of prior art described in above each example, often allows medicated powder be exposed to for a long time in the ambient atmosphere, and this depends on the design of inhaler and the design of metered doses of medicament container.The shielding part character of container embodiments is not touched upon, and having stayed so unanswered problem is how to come the packaged fine silt medicament of appropriate protection reliably in transportation, storage and in using.The product of some prior arts must be before the user can begin an imbibition cycle be opened container allows medicament inject an aerochamber.In some cases, medicament can easily be had a mind to for the user before normal imbibition cycle begins or not suck to meaning.Sometimes, said vesse can be user's first time effect and opens, but the suction effect of the container of from then on opening then controllably is not delayed, and this is because the user understands due to somehow or other distracts.No matter because of what reason, comprise the technological deficiency that container-inhaler is combined, when causing powder medicine and being exposed in the atmosphere, such time must lack as much as possible, so that pharmacy quality undergoes no deterioration before suction.In addition, the interests for the user are definitely to allow the behavior mistake.
So just need the novel high integrity container of the improved dry powder pharmaceutical of packing into, be fit to be inserted in the novel reliable inhaler that is perfectly safe, to guarantee that this medicament is carried out consistent high-quality dispensing.
General introduction
The invention discloses the high cask flask that a kind of medicament uses is so-called box, and in order to the dry powder pharmaceutical of directly packing into and measuring, the sealed foil of the high shielding of this medicament utilization prevents that it from being the particularly pollution of moisture of foreign substance, protects thus and keeps the fine powder medicament.Above-mentioned box is to be used for being inserted in the Diskus, and this sealed foil will be opened, and directly carries medicine by sucking from then on box.The invention also discloses a kind of method, in order to dry powder pharmaceutical is directly flowed to the user of DPI from box, when the sealed foil of box was opened, medicated powder nebulized to scatter and enters in the inhaled air.
The target that the present invention realized is, above-mentioned box can not opened before the user begins to suck by DPI when being used for DPI, make to discharge a required minimum pressure of setting by the effect that sucks before opening operation, this sealed foil for example cracks in the relative motion that the opener is engaged in respect to this box or is torn thus.
Another target that the present invention realized is before air-flow is guided to medicated powder, to make this air velocity that enters among the DPI because of suction increase to a high speed.
In another aspect of this invention, the sealed foil of having opened is folded into the one side away from medicament, therefore can allow the vacuum noz(zle) freely get at all medicated powder in air-breathing.
A kind of dried medicated powder inhaler device disclosed again on the other hand of the present invention, it can be used to admit at least one metering with inclosure the box of medicament, this box is when having at least a minimum suction to be added on this inhaler device, and an opening tool that can install is thus opened box.The medicated powder of being enclosed is suction nozzle suction for this reason when having formed the minimum speed that enters the air-flow in this vacuum noz(zle).
By independent claim 1 and 19 and subordinate claim 2～15 and 20～26 explanations, the medicated powder carrying method is then by independent claim 16 and subordinate claim 17 and 18 explanations respectively for above-mentioned dried medicated powder inhaler device.
The accompanying drawing summary
The present invention and its other objects and advantages can get the best understanding with reference to the detailed description of doing below in conjunction with accompanying drawing, in the accompanying drawing:
Fig. 1 a, 1b, 1c have illustrated first embodiment of box from principle with vertical view and side view;
Fig. 2 a, 2b, 2c have illustrated second embodiment of box from principle with vertical view and side view;
Fig. 3 a, 3b, 3c have illustrated the 3rd embodiment of box from principle with vertical view and side view;
Fig. 4 a, 4b, 4c have illustrated the 4th embodiment of box from principle with vertical view and side view;
Fig. 5 a, 5b, 5c have illustrated the 5th embodiment of box from principle with vertical view and side view;
Bright from the principle six embodiment of box before it is sealed that medicament is housed of Fig. 6;
Bright from the principle seven embodiment of box before it is sealed that medicament is housed of Fig. 7;
Bright from the principle eight embodiment of box before it is sealed that medicament is housed of Fig. 8;
Fig. 9 illustrates from the method for these box dispensings.
Invention is described
The invention discloses a kind of novel medicine container is a kind of so-called box, and with it as for sucking the packaging part use segmentation dry powder pharmaceutical through measuring, this packaging part then for this reason medicament to foreign substance particularly moisture the sealing of high shielding is provided.Metered doses of medicament container of the present invention, box can have the dry powder pharmaceutical of different size and shapes to adapt to selected dried medicated powder inhaler device and to select for use.Dosage can make this box can be used for loading the medicament and the dosage material that comprises in this scope of 50 μ g～50mg according to medicament and the change of its usefulness.
Fig. 1 a, 1b, 1c, 2a, 2b, 2c, 3a, 3b, 3c, 4a, 4b, 4c, 5a, 5b and 5c have shown and have been applicable to pack into five different embodiment of the box on its metered doses of medicament bed of dry powder pharmaceutical, they propose as non-limitative example, and the label 10～20 among three figure of each embodiment refers to identical parts respectively.
Fig. 1 a and 1b show two side views and 1 vertical view of an embodiment who understands box 13, and box 13 comprises a dosage bed 10, sealing surface 11 and the high shield gasket paper tinsel 12 that has the beveled end parts.Shown in bright sealing member be to have used situation on the box at it.Fig. 1 c understands the metered doses of medicament 20 that is encased in the box of preparing sealing to overlook with the side-looking diagram.
Fig. 2 a and 2b show two side views and a vertical view of understanding box 13 another embodiment, and box 13 comprises metered doses of medicament bed 10, sealing surface 11 and has high shield gasket paper tinsel 12 than the less inclination among Fig. 1 b.Shown sealing is the situation before it is applied on the box.Fig. 2 c understands the metered doses of medicament 20 that is encased in the box of preparing sealing with vertical view and side-looking diagram.
Fig. 3 a and 3b show two side views and a vertical view of understanding box 13 another embodiment, the high shield gasket paper tinsel 12 of arc that box 13 comprises metered doses of medicament bed 10, sealing surface 11 and do not have sharp bend.Shown sealing is the situation before it is applied on the box.Fig. 3 c understands the metered doses of medicament 20 that is encased in the box of preparing sealing with vertical view and side-looking diagram.
Fig. 4 a and 4b show and understand box 13 two side views and the vertical view of an embodiment again that box 13 comprises metered doses of medicament bed 10, sealing surface 11 and a high shield gasket paper tinsel 12.Shown sealing is the situation before it is applied on the box.Fig. 4 c understands the metered doses of medicament 20 that is encased in the box of preparing sealing with vertical view and side-looking diagram.
Fig. 5 a and 5b show and understand that box 13 two side views and the vertical view of another embodiment again, box 13 comprise that metered doses of medicament bed 10, sealing surface 11 and be not with the smooth high shield gasket paper tinsel at sharp turn.Shown sealing is the situation before it is applied on the box.Fig. 5 cc understands the metered doses of medicament 20 that is encased in the box of preparing sealing with vertical view and side-looking diagram.
The embodiment of box 13 shown in Figure 6 has adopted the part cylindrical element, is included in metered doses of medicament bed 10, the sealing surface 11 on the part cylindrical element inwall and is enclosed in metered doses of medicament 20 on this metered doses of medicament bed.The sealed foil of box is not shown.
The embodiment of box 13 shown in Figure 7 has adopted the part cylindrical element, is included in the metered doses of medicament 20 on metered doses of medicament bed 10, the sealing surface 11 on the part cylindrical element outer wall and this metered doses of medicament bed of packing into.The sealed foil of box is not shown.
Fig. 8 shows bright box 13 another embodiment again, and having adopted almost is whole cylindrical element, is included in metered doses of medicament bed 10, sealing surface 11 and the metered doses of medicament 20 that is contained on this metered doses of medicament bed on the part cylindrical element inwall.The sealed foil of box is not shown.
These shown embodiment are schematically, are interpreted as the explanation of structural meaning.For example, the shape of described box, metered doses of medicament bed and metered doses of medicament all is orthogonal in the drawings.But squarely also be fine naturally, square is orthogonal special case, and in fact general ellipse or circle are fine equally.The typical sizes of box is 2 * 2mm～10 * 40mm and the size in this scope.The box height is 0.5～5mm.
Fig. 9 shows bright method from the box dispensing.
In the present invention's one most preferred embodiment, box dry, moisture vapor transmission gas, direct loading and sealing is not encapsulating the dried medicated powder that measured, and the box here is that arrangement is layed among the DPI with the medicament that is encapsulated into, and is used for when box is opened medicament being exported.
Another most preferred embodiment of the present invention is a box that has sealed, it has the smooth or arcual dry powder pharmaceutical that is used as the bottom of metered doses of medicament bed with load measurement, the top seal paper tinsel of box is arranged to can be an opening device and is opened, and second from first of box to box tears apart the latter with this paper tinsel.The breakthrough point of paper tinsel for example needn't be identical with exit point.
A most preferred embodiment more of the present invention is a kind of seal box, and described paper tinsel is arranged to can be for an opening device that moves tears apart, and this opening device also is folded to paper tinsel the aspect of the medicament that disengaging seals; This gag that moves is located a vacuum noz(zle) by the neighbour and is followed the track of himself, gets at gradually at it and just aspirates this medicated powder when utilizing this vacuum noz(zle).Perhaps, this box can be with respect to the motion of opening device and vacuum noz(zle), and this back both can be fixed in the adaptive inhaler device.In addition, box, opening device and gas absorption spray can be arranged to move with respect to the getter device of carrying packaged medicament.
In another most preferred embodiment of the present invention, selected seal box promptly is torn out the metered doses of medicament that encapsulates in suction activity once then be that vacuum noz(zle) sucks.Be the medicine activity component (API) at least 30%, better at least 50% of metered doses of medicament preferably at least 70% or more by weight at fine powder medicament that this sprayed.The fine powder medicine that is ejected can not be higher than the fine powder medicine ratio of the composition of API as the percentage ratio of metered doses of medicament.
, have more than a selected seal box and open by fixed sequence again again among the embodiment of the present invention, the medicament that encapsulates in each corresponding box is then once sequentially sucking by vacuum noz(zle) in the suction activity.
Another most preferred embodiment again of the present invention is the seal box among a kind of DPI of being inserted in, the sealed foil that it has is designed to can be torn out and be folded to the direction that is separated from packaged medicament, wherein triggers opening of this box when at least one selects the pressure of inspiration(Pi) of threshold value to affact the vacuum noz(zle) of DPI.At this, unless development has the air velocity of abundant size to guarantee powder medicine to be atomized effectively and eliminate caking selectively in vacuum noz(zle), vacuum noz(zle) is can not lead to packaged medicament.
The present invention again again a most preferred embodiment be such seal box, it is vacuum noz(zle) when sucking medicated powder when opening, and begins to end from the drug delivery order, for the air-flow that enters the vacuum noz(zle) inlet provides the symmetric condition of consistent and uniform and equal medicament accessibility.
The present invention's another most preferred embodiment again is such seal box, make and to open and towards breaking away from the medicament direction when folding when sealed foil, as long as sufficient suction is arranged to vacuum noz(zle), medicament just can atomize fully and enter in the vacuum noz(zle), and the powder that remaines in the box can be minimized, be no more than by mass this metered doses of medicament active constituents of medicine 30%, be no more than 20% and be no more than 10% preferably the time when better.
Box of the present invention is used for being inserted in the dried medicated powder inhaler device, and this device, is arranged to export one or more metered doses of medicament simultaneously for the user begins to offer medicine in each air-breathing activity during more than one at box.In an embodiment of the present invention, be arranged to by this inhaler, the once air-breathing activity of user once has a box to be used for carrying the metered doses of medicament of encapsulation.The design of inhaler is being controlled and how box can be inserted in the inhaler and the number of the box that can insert and use before it becomes the string box that must provide new.Another kind of embodiment need have at least a box at first to be installed to carrying of box to hold on the part, then held part this year and install in the inhaler.
Here used phrase: the phrase of " choosing from the group that is constituted ", " being selected from " and similar meaning comprises clear and definite mixtures of material.
Here all lists of references of narrating, application documents, test, standard, file, publication, delete son, text, paper and description etc. for a short time, all comprehensively for reference in this manual.When stating numerical value limit or scope, comprise two end value.Simultaneously, all values in numerical value limit or scope is also included within wherein with regulation among a small circle, as its situation of going out of clear expression.
Container of the present invention or box have adopted high shield gasket, can highly block moisture and other foreign substances, be fit to be inserted in the dried medicated powder inhaler device, and this container or also can be the part of suction apparatus.
Here used " doing or drying " speech refers to, for example wall of a container is to be made by the material of selecting, and/or this material handled already and make wall of a container particularly the inner wall surface of container can not discharge water outlet so that influence dried medicated powder dosage and reduce FPD.As its logical consequence, the structure of container and material are unnecessary Germany bulletin DE 101 26 924 A1 (US2003 070679) processing advised.For example gelatin is not a drying material, even through special dried, gelatin is still moisture.Generally, " drying " is meant that the FPD of medicine is not subjected to the influence of related material.
" high shield gasket " refers to the dry packing structure or the combination of material or different materials.High shield gasket represents highly to stop moisture or other foreign substances, and this sealing simultaneously itself is " exsiccant ", but promptly its medicated powder that can not pack into the moisture of quantitation.High baffle seal for example can be by the one layer or more material, and promptly industrial polymer, aluminum or other metals, glass, silicon dioxide etc. constitute high shield gasket together.If this high shield gasket spare is a paper tinsel, then 50 μ m PCTFE/PVC medicine paper tinsels are useful especially high curtains.For this reason, preferably select the metal forming that the long period stability in use is arranged of the aluminium foil that can buy from Alcan Singen and so on.
" high cask flask " is a kind of frame for movement, and preparation is used for protection and encapsulated agents tiotropium (trade name of chronic obstructive pulmonary disease curative) for example.High cask flask is to constitute this wall of a container portion with high shield gasket spare." box " speech is to be used for describing so high cask flask in these application documents, it is characterized in that having the bottom and be suitable for the dry powder pharmaceutical of accepting by method meterings such as volume filling, gravity filling or electronic fillings, and have the feature for the paper tinsel sealing in addition, this paper tinsel can be torn or peel off so that vacuum noz(zle) can get at packaged medicament by opening device.
" directly packing into " refers to the metered doses of medicament high cask flask of directly packing into, does not for example promptly need at first medicament to be loaded in the capsule and then with one or more this initial property container (capsule) to be encapsulated in the secondary packing of high shield gasket material.
The most handy permission of high cask flask that is used to contain medicament directly contacts the aluminium foil of medicine and makes.The aluminium foil that is suitable for this respect generally is made up of the industrial copolymer of aluminium foil lamination, so that this paper tinsel has the engineering properties that matches, avoids the aluminium cracking in the forming process.The aluminium foil example that is applicable to this box is can be available from the 115-0085E type of Alcan Packaging Lawson Mardon SingenGmblt.Paper tinsel of the above-mentioned end is a kind of laminated piece, comprises the aluminium foil of 45 μ m, at 25 μ m orientation polyamide (OPA) films of the matt side of this aluminium foil and at 30 μ m rigid PVC films of the bright side of this aluminium foil.This kind lamination paper tinsel can synthesize the formation required form.The container of Xing Chenging normally seals with the thin lid paper tinsel of fine aluminium or aluminum and polymer stack like this.The alumiseal paper tinsel that is applicable to this box for example has the 113-0049E type available from Alcan Packaging Lawson Mardon SingenGmbH.Above-mentioned sealed foil is a laminated piece, comprises 9 μ m aluminium foils and at 6 μ m polyester films of the bright side of this aluminium foil and at the heat seal glued membrane of the matt side of this aluminium foil.This container and lid paper tinsel then can be with at least a being sealed together in several possibility methods below for example according to the structure of material therefor and paper tinsel:
Use the heat seal glued membrane, by pressurization and heating;
Adopt heating the material clinkering to be arrived with pressurization;
With ultrasonic bond that relevant material is welded together.
Described container is with respect to preferably the have an appointment sealing of width to guarantee that high-quality nothing is sewed of 2.5mm of the two sealing surface of paper tinsel.
Seal box of directly packing medicine into of the present invention comprises smooth or arcual metered doses of medicament bed, for example forming cavity in aluminium foil or the molding cavity in the polymeric material, the sealed foil that adopts high shielding is to stop for example intrusion of aluminum or aluminum and polymeric material conjugate of moisture and other foreign substances.The exsiccant high shielding box of this sealing can form the part of inhaler device, maybe can be formed for being inserted to the part of dispensing with an individual devices in the suction apparatus.This seal box for example can have following data as the indefiniteness example:
Container interior volume: 100mm 3
Effective diffusion area: 46mm 2
Diffusion constant: 0.044g/m 2, 24 hours, in 23 ℃ with local Rh=50% under.
Show that with different modes in above-mentioned example, the speed that water is diffused in the box is per 24 hours 20g/m 3, under 23 ℃, and suppose that local Rh is 50%.For example result of the test shows, the high shielding box of the sealing of above-mentioned size does not preferably make water when keeping the tiotropium medicament transfer rate in 24 hours greater than 20g/m 3, 23 ℃ with local Rh=50% condition under, the service time when being fit to this condition is the longest to be 2 weeks.Above result can be transformed to one group and use for example requirement on the blister spare of dissimilar containers.Have the blister spare of similar size can be with box in this example with typical high-quality material as 50 μ m PCTFE/PVC, and this material satisfy just aforementioned box diffusion constant (38 ℃ with 90%Rh under be 0.118g/m when calculating again 2) requirement.If want to allow the box that contains medicament tiotropium can use the above long period in two weeks, then must employing more can protect FPD by moistureproof box.
In US 2003/0140923 A1, discuss application " the effective helping method in the time of can not realizing high shield gasket " and protected the method for the container that is filled with dried medicated powder.In US 6,130,263 and US 5,432,214 in, insert moisture absorption desiccant in the material and be formed at the chamber and paper tinsel in the protection medicine.
Above patent application and patent have been discussed in the material that desiccant can be joined container or have been added within the suction apparatus or in its outer package.This method is not new, and the Turbuhaler (trade name) by Astrazeneca used on the market more than 20 years.Turbuhaler is provided with the silica gel of some or the mixture of dissimilar desiccant in suction apparatus, with the dried medicated powder of protection between in use and in the holding time.Tarbuhaler also has outer package, with protector in the holding time before opening.The Taifun of Focus Inhalation (trade name) comes dry powder pharmaceutical in the protector with desiccant.This dry dosage is generally very little in this class formation, and then still identical in the face of the requirement of high shield gasket protection medicated powder, not so this desiccant also can be used on before corresponding product comes into operation.
Atomize before the crash time for FPD being remained to medicament, WO 02/24266 A1 (US 6,651,341) has discussed the method that before medicament begins to atomize part is opened medicine container second, and wherein disclosed content is incorporated herein by reference.This respect it is also important that the DPI user that prevents to get at selected medicament and will suck medicament has a mind to or by mistake carry out respiratory activity, and this is because in breathing suck very high humidity is arranged.US6, disclosed related content is incorporated herein by reference among 439,227 B1, and wherein disclosed device is closed DPI when the user plans to exhale, thereby the air of breathing out can not arrive the medicament of selecting for use among medicine container and the DPI.This kind device is also being controlled devoting oneself to work of cutting member and vacuum noz(zle), unless make because the gettering effect of user and the pressure that shows certain selection the earliest when falling, cutting member is can not open container and the air breathed can not begin the medicament that atomizes.
Once suck the inhaler that can prolong the drug delivery time the active process from the high shield gasket container of aluminium foil manufacturing and constituted inhaler-most preferred embodiment in order to the delivery of dry powder medicament.The described air of US 2003/0192539 A1-razor method can be advantageously used in inhaler, with the medicament that effectively and little by little atomizes when giving user with drug delivery.
Now the most important aspect of most preferred embodiment of the present invention is summed up, as the box of the high shield gasket container of dry powder pharmaceutical should:
● the lid paper tinsel of box is arranged to, on the contrary when an opening tool be opening device with respect to box do relative motion or the time can penetrate paper tinsel at an end of box, paper tinsel is torn and make it to draw at the other end of box, and this breakthrough point preferably is different from the leading point;
● above-mentioned opening device is generally integral body and is attached among the DPI, and perhaps its associated components also can be sprawled towards being separated from metered doses of medicament bed zone this sealed foil with the direction of medicament, makes the suction nozzle of following the opening device motion track can get at medicated powder;
● the paper tinsel of drawout can be gone back near the home position by the appropriate device among the DPI, and the medicated powder that stays so just is difficult for overflowing from box;
● the metered doses of medicament bed zone at the bottom of the box is smooth or arcual, makes that the distance between metered doses of medicament bed and vacuum noz(zle) can reasonably remain unchanged, like this flow conditions that can be consistent when delivery of medicaments.
In prior art, open the metered doses of medicament container in DPI so that medicament can suck realizes in many ways.If adopted medicine bag, then this medicine bag is for example poured out its contained object among the DPI in the district placed in the middle in two, then in medicated powder is atomized herein.Another kind of general method is to get out one or more hole on medicine bag, sucks air in the medicine bag and vibrates medicine bag selectively, so that medicated powder atomizing and sucking-off from medicine bag.Then the lid paper tinsel can be peeled off in the situation of blister spare container, be able to directly get at medicament or medicament is poured out in the inhalant mesozone from the bubble spare of opening.
Like this, the container of prior art or medicine bag first step be open it and in second step, begin the atomizing.Depend on that in this step 1 and the time between the step 2 technical scheme that is adopted is different from a DPI to next DPI, but in most cases, this time is uncertain but has arbitrariness according to the operation of user, can be some minutes and some hrs.If medicament is owing to being subjected to injurious effects in the internal and external environment that is exposed to DPI, this considers it is unallowed from the medical science viewpoint.
Another shortcoming of prior art container is, being used to of being inhaled into, the atomize air-flow of medicament can have influence on all medicated powder at the same time, thereby the shearing force of this air-flow can be distributed on the very big zone of storing medicament, agglomerate in this medicament and granule depend on their distributions with respect to air-flow, can be subjected to the influence of very different, not controlled shearing forces randomly.Overwhelming majority medicated powder is with the variable interval instantaneous output in ground.Container for example capsule or blister spare since sharp-pointed device or needle set form when porose, the edge of broken container material will bend towards medicament, this edge of this moment can enter in the container by disturbing flow, make some part of medicament fail suitable atomizing with eliminate caking.
In some cases, all medicated powder is not subjected to the influence of same shear stress, and this is owing to air-flow is to be distributed in unevenly on the medicament or by medicament.This tendency further hinders the particulate medicament of output and has strengthened the ratio of retaining medicament in the container.
Another problem is related generation when medicament atomizes in the prior art container, and promptly the speed of this atomization air flow is initial from zero when atomization process begins.The result makes most medicaments apace with caking form input, and these agglomerates then can not be eliminated caking enter the air flue of user at the air duct by DPI before fully.
Because above-mentioned shortcoming is difficult to high level ground elimination caking as one man, the particulate medicament of being exported then is a less percentage ratio of this metered doses of medicament.
The present invention has solved the problem of many prior arts on the other hand, the present invention's one most preferred embodiment is in being applied to the DPI of appropriate designs the time, for example before opening valve respective air passage enters the vacuum noz(zle) that links to each other with DPI one suction inlet again in by air admission DPI, need apply certain suction earlier to this suction inlet.Can guarantee like this around the ingate of vacuum noz(zle), to begin to form higher air velocity.Open sealed foil operate in the opening of air valve the time just end, but at opening device once-existing interbody spacer before a place of box opens sealed foil.In the relative motion of opening device with respect to box, this paper tinsel is little by little to crack and simultaneously towards pleated away from the direction of medicament.Vacuum noz(zle) is followed the motion track of opening device, but during the nearest medicated powder in vacuum noz(zle) arrives box, the air velocity that enters the vacuum noz(zle) ingate has accelerated at a high speed, is enough to discharge medicated powder and eliminates any powder agglomates that gets at selectively when having any powder ball after moment.Follow the motion track of opening device closely, medicated powder is atomized and eliminates simultaneously where necessary caking gradually.Distance between vacuum noz(zle) ingate and the metered doses of medicament bed is kept roughly constant, just can guarantee to enter the shearing force uniform distribution of the air-flow in the vacuum noz(zle), and its whole potential can be used for whole medicated powder are atomized and eliminate caking, no matter medicated powder is where to be positioned at go the medicament bed of box,, medicament gets final product so long as being present in vacuum noz(zle) motion zone in one's power.The hold-up of medicated powder reduces to minimum.Medicament is exposed in the atmosphere and is transported to the time of user air flue between the two extremely part second just of weak point-usually significantly, thereby has guaranteed that medicament can not be subjected to the influence of ambient air as much as possible when sucking.
When the paper tinsel of opening had the edge of drawout not, these marginal portions might be the DPI original position of turning back.This is to I haven't seen you for ages partly with box sealing, makes any powder that is stranded in the box can not fall in the device of DPI or enters in the air flue and can influence the operation of DPI or jeopardize user.
Above-mentioned explanation of the present invention provides mode and the method for using it, can make any one skilled in the art can utilize the present invention, this probability is particularly provided by the subject content of appended claim book, these accompanying Claim have constituted the part of this primary description, content comprises the kit that is encapsulating the dry powder pharmaceutical that is used for dried medicated powder inhaler, it is characterized in that first component of this dry powder pharmaceutical comprises at least a pharmaceutically active composition; This container is formed with dried high shield gasket spare, and the high shield gasket of this container has just prevented the particularly intrusion of moisture of foreign substance, has so just kept the original fine silt of dry powder pharmaceutical to form; Dry powder pharmaceutical in this container is applicable to the medicament formation method container metering or the electric field metering simultaneously.
Other embodiment then comprise from following material or select the situation of exsiccant high shield gasket spare where necessary from the combining forms of these materials, and this class material comprises: metal (comprising aluminium foil), thermoplastic, glass, silicon, silicon dioxide.
More than just by way of example mode be described, the people who this technology is had a general knowledge do not break away from the appended claim book be the multiple modification that can recognize these disclosed embodiment in clear and definite spirit and the scope.

Claims (26)

1. carry the medicine container of dry powder pharmaceutical of containing metering, it is characterized in that in order to offer medicine by dry powder inhaler device:
This medicine container forms a box, has the end of carrying the medicament bed that holds this metered doses of medicament as being applicable to;
This metered doses of medicament is packed in the above-mentioned box and has promptly been avoided the particularly intrusion of moisture of foreign substance after sealing this box by high shield gasket paper tinsel, makes this box convert high cask flask in order to the encapsulation metered doses of medicament to thus;
Above-mentioned box-like becomes makes the sealed foil of this box to make the opening tool of this inhaler device of mutual relative motion by setting box therewith for, starts from first of box and terminate in second of box to open, perhaps opposite.
2. the container of claim 1 is characterized in that:
Described box has the flat bottom as the medicament bed.
3. the container of claim 1 is characterized in that:
Described box has the curved bottom as the medicament bed.
4. the container of claim 1 is characterized in that:
Described cutting member is folded to it direction that breaks away from medicament immediately after will protecting the medicament sealed foil to open, medicament can be got at for sucking air-flow.
5. the container of claim 1 is characterized in that:
The box of this sealing be suitable for directly being inserted in the inhaler device so that the medicament of encapsulation can by inhaler device from then on box directly import.
6. the container of claim 1 is characterized in that:
Carrying of box hold on the part tipping have at least one seal box, this box to be fit to be inserted in the inhaler device so that the medicament of encapsulation thus inhaler device directly import from a selected box.
7. the container of claim 1 is characterized in that:
Selected the box that can be used for sucking in the dry powder inhaler device operation;
This box is set for and is made when the suction that surpasses a predetermined value is on inhaler device, and the sealed foil of the box cutting member in the inhaler device for this reason cracks.
8. the container of claim 7 is characterized in that:
Be loaded into the medicament atomizing on the medicament bed of this selected box and suck by air-breathing and in the inspiratory flow that forms, the sealed foil of while box is opened and by the medicated powder that has in the inhaler device delivery cartridge.
9. the container of claim 8 is characterized in that:
The metered doses of medicament of described encapsulation is that vacuum noz(zle) sucks once sucking in the operation, and the particulate pharmaceutical quantities of carrying thus be by weight described metered doses of medicament medicine activity component at least 30%, be more preferably 50%, preferably 70%.
10. the container of claim 1 is characterized in that:
The medicament of described box and encapsulation is arranged to can be used to carry out drug delivery over a long time in being applied in the selected dry powder inhaler device of keeping long-time drug delivery the time.
11. the container of claim 1 is characterized in that:
Above-mentioned dry powder inhaler device comprises vacuum noz(zle);
Before the mouth, vacuum noz(zle) is can not get at medicament to the medicament that this vacuum noz(zle) and aforementioned box are arranged to make encapsulation before having abundant turbulent air velocity development to enter into to inhale, and has guaranteed that thus medicated powder can atomize effectively and eliminates caking.
12. the container of claim 1 is characterized in that:
After described sealed foil cracked, the box of being opened provided symmetric concordance flow conditions and constant medicament accessibility for the air-flow that enters vacuum noz(zle) at this moment.
13. the container of claim 12 is characterized in that:
When medicament was exported from box already, described sealed foil edge folding goes back to the home position, at least partially the medicated powder of any delay is closed in this box thus.
14. the container of claim 1 is characterized in that:
The metered doses of medicament of described encapsulation sucks once sucking in the operation by vacuum noz(zle), make thus in the box the medicated powder retention rate by weight for this reason the metering medicaments active component of medicament less than 30%, better less than 20% preferably less than 10%.
15. the container of claim 1 is characterized in that:
There is two or more box to insert in the inhaler device, makes medicament in two or more box since then can use in the once suction operation that inhaler device carries out, as required in regular turn or input simultaneously according to predetermined operating type.
16. the dry powder pharmaceutical that will be packaged in the metering in the sealed container flows to the method for dry powder inhaler device, the method is characterised in that and comprises the steps:
First step, the user applies second end that the suction that surpasses certain threshold value gives vacuum noz(zle) to cause an air-flow that enters this vacuum noz(zle) second end, makes the gas velocity that enters vacuum noz(zle) surpass a selected minimum speed thus;
Second step, opening selected sealed container is so-called box, meanwhile makes first end of the medicament arrival nozzle of encapsulation;
Third step, the air-flow that medicated powder in the opened box can be entered before the vacuum noz(zle) gets at and this approaching medicated powder that atomizes.
17. the method for claim 16 is characterized in that also having following step:
Between opening tool and vacuum noz(zle) one side and box the opposing party, introduce relative motion, make this opening tool open sealed foil and with its bending away from, the medicament bed moved at the bottom of this vacuum noz(zle) then was roughly parallel to box, and thus, this vacuum noz(zle) is asymptotic medicament under the flow conditions of unanimity.
18. the method for claim 17 is characterized in that also having following step:
Described box, medicament are arranged to relative medicament medicament motion with vacuum noz(zle), make air velocity when this vacuum noz(zle) begins promptly to measure at the bottom of move to box bed from motion distribute equably to enter into this vacuum noz(zle) inlet around, can when delivery of medicaments, keep good atomization condition thus.
19. comprise the dry powder inhaler device of opening tool and vacuum noz(zle), it is characterized in that:
This inhaler device can be used to install at least one claim 1 medicine container or is box;
When will be above the suction of predetermined value during in this inhaler device, above-mentioned opening tool just crack operation the plug-in mounting box of going into open;
When being deferred to the air-flow that enters in the vacuum noz(zle) and surpassing the air velocity that presets to entering medicated powder in the vacuum noz(zle) just with its atomizing.
20. the inhaler device of claim 19 is characterized in that:
Described inhaler device is when adopting the box be arranged for long-time delivery of medicaments during with encapsulated agents, can make long drug delivery once sucking in the operation maintenance.
21. the inhaler device of claim 19 is characterized in that:
Packagedly once sucking in the operation to vacuum noz(zle) sucks to the metered doses of medicament in a selected box, and thus the particulate pharmaceutical quantities of conveying be by weight described metered doses of medicament medicine activity component at least 30%, be more preferably 50%, preferably 70%.
22. the inhaler device of claim 19 is characterized in that:
The box of being opened provides symmetric concordance flow conditions and constant medicament accessibility for the air-flow that enters vacuum noz(zle), and it sucks medicament gradually and make its atomizing in the process that sucks.
23. the inhaler device of claim 19 is characterized in that:
After medicament was exported from box, described sealed foil edge folding went back to the home position, at least partially the medicated powder of any delay was closed in this box thus.
24. the inhaler device of claim 19 is characterized in that:
There is two or more box to insert in the inhaler device, makes and to use in the once suction operation that inhaler device carries out, according to the predetermined operation mode in regular turn or input simultaneously according to needs from the medicament in this two or more box.
25. the inhaler device of claim 19 is characterized in that:
Described box can be used to accept the pharmaceutical quantities of 50 μ g～50mg and is included in the interior pharmaceutical substance of this scope.
26. the inhaler device of claim 19 is characterized in that:
Described inhaler device can be used to receive a box, and this box carries pharmaceutical quantities that becomes to have in 50 μ g～50mg scope and the pharmaceutical substance that is included in this scope.
CNA2005800200064A 2004-06-18 2005-06-09 Inhaler using pods Pending CN1968670A (en)

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SE0401612A SE530006C2 (en) 2004-06-18 2004-06-18 Inhaler using tub

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CA2570118A1 (en) 2005-12-29
MXPA06014501A (en) 2007-03-23
RU2006146879A (en) 2008-07-27
JP2008502416A (en) 2008-01-31

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